ACUNAV SWIFTLINK CABLE
Received Apr 4, 2017 · Event occurred Mar 10, 2017
Report 3009498591-2017-00131 · MDR key 6458045
Device
Generic name
Catheter Connector
Manufacturer
Siemens Medical Solutions Usa, Inc.Model number
ACUNAV SWIFTLINK CABLECatalog number
08255715
Lot number
N/A
Product problems
- Connection Problem
- Connection Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO SIEMENS FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED OR IF THE DEVICE IS RETURNED AT A LATER DATE, THIS REPORT WILL BE SUPPLEMENTED.
Description of Event or Problem
IT WAS REPORTED THAT WHILE THE PATIENT WAS IN THE OPERATING ROOM (OR) IN THE MIDDLE OF UNDERGOING AN INTRACARDIAC ECHOCARDIOGRAPHY (ICE) STUDY, THE CATHETER AUTOMATICALLY FROZE AND CANNOT KEEP ACTIVE IMAGE AS SOON AS IT WAS CONNECTED TO THE ULTRASOUND SYSTEM. THE USER REBOOTED THE SYSTEM TWICE AND IT STILL FAILED. THE USER CHANGED TO ANOTHER SWIFTLINK ADAPTER AND REBOOTED THE SYSTEM AGAIN. THIS TIME THE SYSTEM WORKED AND THE STUDY WAS CONTINUED AND COMPLETED. THERE WAS NO LOSS OF DATA BUT THERE WAS A DELAY OF 20 MINUTES WHILE THE REPLACEMENT SWIFTLINK ADAPTER WAS OBTAINED. THERE WAS NO PATIENT ADVERSE EVENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL MANUFACTURER NARRATIVE. MANY ATTEMPTS WERE MADE TO REQUEST THE RETURN OF THE SWIFTLINK CABLE INVOLVED WITH THE REPORTED INCIDENT. WE DID NOT RECEIVE THE CABLE AND WERE UNABLE TO CONFIRM OR REPRODUCE THE ISSUE BASED ON THE INFORMATION PROVIDED. NO INVESTIGATION COULD BE PERFORMED.